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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00185328 | Other Identifier | JHM IRB |
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No subjects were enrolled
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purposed of this research is to study the safety and clinical activity of the combination of nivolumab and cabiralizumab in people with resectable biliary tract cancers (BTC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Nivolumab | Experimental |
| |
| Arm B: Nivolumab and Cabrilizumab | Experimental | Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes, a 30 minute rest, followed by cabiralizumab every 2 weeks. (Cycle length 2 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing study drug-related toxicities | Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0 | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Number of months from the date of first treatment until death or end of follow-up. | 4 years |
| Disease free survival (DFS) | Number of months until disease recurrence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Murphy, MD | Johns Hopkins Medical Institution | Principal Investigator |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Cabrilizumab | Drug | Cabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks. (Cycle length 2 weeks). |
|
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| up to 4 years |
| D004066 |
| Digestive System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |